Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination in a medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Madison Polymeric Engineering is recalling the First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3. The recall involves 115 cases, totaling 11,500 kits. The affected lot numbers are EX20190105P, EX20190108P, EX20190109P, and EX20190110P.
The products are being recalled because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The agency has classified this as a Class II recall.
The products were distributed to numerous US states, including AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
- Manufacturer
- Madison Polymeric Engineering
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: EX20190105P
- EX20190108P
- EX20190109P
- EX20190110P
Distribution
Part of a larger recall action
This product is one of 6 recalled by Madison Polymeric Engineering under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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